Bionovus Life Sciences

Pharmaceutical Microbiology: Interview with an Industry Expert

MicroBioLogics recently had the opportunity to interview President and Founder of Veracorp, LLC, Frank Settineri. Veracorp assists pharmaceutical, biotech, medical and startup companies with meeting regulatory guidelines and running their business' efficiently. With over 30 years of experience, Settineri is an authority on Good Manufacturing Practices (GMP) compliance, validation planning, outsourcing, and investigating and rectifying microbiological issues.

In the interview, Settineri discusses Growth Promotion Tests in the pharmaceutical microbiology laboratory. He also shares his views on current challenges that pharmaceutical microbiologists are facing and the recent harmonization of several microbiology tests in the United States Pharmacopeia (USP), Japanese Pharmacopoeia (JP) and European Pharmacopoeia (Ph. Eur.) Read Frank's responses to our questions in the full article.

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AmpC Disk Test Controls Coming Soon

MicroBioLogics® will soon have the positive controls available for the AmpC Test. The AmpC Disk Test is used for detecting AmpC beta-lactamases.

AmpC β-lactamases are found on a chromosome of several gram negative bacteria such as Enterobacter cloacae and Serratia marcescens. They may also be found on transmissible plasmids in bacterial species that lack an inducible chromosomal enzyme such as E. coli, Klebsiella ssp., Salmonella ssp. and Proteus mirabilis. Plasmid-mediated AmpC β-lactamases can be harder to detect. They may give false susceptible results when tested with cephalosporins.

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MicroBioLogics® Supplies Original Reference Cultures from International Culture Collections

As you probably already know, MicroBioLogics manufactures authentic and traceable lyophilized microorganism derivatives for Quality Control testing. What you may not know is that MicroBioLogics is also a licensed supplier of original reference cultures from world renowned culture collections including NCIMB, NCTC and NCPF.

The term "original reference culture" is used to describe microbial cultures that are supplied directly from a culture collection. A culture collection is a biological resource center that acquires, authenticates, maintains, preserves and distributes biological materials for the scientific community. Original reference cultures are usually used for research purposes.

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New Easy to Read Product Labels!

MicroBioLogics recently made some improvements to our product labels. The new labels are brightly colored and easy to read at a glance. The product name is prominently displayed for easy identification. Also, many products feature a peel-off label which provides complete documentation at your finger tips. Check out our new and improved labels with your next order from MicroBioLogics!

Meet the MicroBioLogics® Customer Service Team

The MicroBioLogics Customer Service team is always available when you have questions regarding product availability, shipping and/or invoicing. If you are not sure who you should contact with a question, Customer Service can direct you to the right person.

Here's a helpful tip from one of our readers:

"Propionibacterium acnes can be a problem contaminant in biopharma-ceutical manufacturing. If you want to detect it in bioburden samples, you will need to incubate your plates under anaerobic conditions and extend your incubation time to 5 - 7 days. However, you do not need to use pre-reduced media or to pre-reduce your standard media before incubation."

Ed Balkovic, Ph.D.
QC Technical Services – Microbiology Genzyme Corporation
 

A. MicroBioLogics® can help you decide which microorganisms are appropriate for your water testing lab. We have a document titled "Selection of Water Microbiology QC Microorganism Challenges" that suggests which MicroBioLogics® microorganisms to use for water tests such as the coliform test. To download this document as a PDF, click here.

We also have a document with detailed illustrated instructions for using Epower™ microorganisms when performing membrane filtration. To download these instructions as a PDF, click here.

This e-mail address is being protected from spambots. You need JavaScript enabled to view it to MicroBioLogics and we will follow up with you personally. Your question may be featured in a future edition of MicroBioLogics Magnified.
 

Need a microorganism strain or enumerated microorganism preparation that is not currently available from MicroBioLogics? Download a Microorganism Request form here:

Lyophilized Microorganism Request Form

We will carefully consider all submissions and follow up with you personally.
 

Take 5, and enjoy a fun microorganism word search! Later, come back for the solution so you can see how you did.
 

MEDICA 2009
November 18 – 21, 2009
Düsseldorf, Germany
 

Performing quality control for antibiotic susceptibility tests? Here are a few tips.

• Use the quality control reference strains recommended by CLSI or panel manufacturer.
• Don't test the colonies growing on the plate that was inoculated with the lyophilized microorganism. The microorganism is not fully resuscitated. It should be subcultured before it is tested.
• Test colonies that are 24 hours old or younger.
• Grow the microorganism in the correct atmosphere. For example, Haemophilus influenzae should be grown in 5% CO2.
• Grow the microorganism on the type of agar recommended by CLSI or the test kit manufacturer.
• Start a new LYFO DISK® or KWIK-STIK™ every two weeks to avoid mutation.
• Use the correct concentration of the microorganism when performing the test.

10/02/2009: Vitek® News

09/29/2009: Etest® Metallo Beta-Lactamase Controls Available Now